KR100514901B1 - Equipment for the treatment of capsular contractures in mammal implants - Google Patents

Abstract

The present invention relates to an apparatus 10 for generating ultrasonic waves by means of suitable means for transmission to the transducer 14 by adjusting the frequency and power range having two operational possibilities, namely continuous mode or pulsating mode. The present invention discloses a harness 16 or similar support means. The leash 16 is attached directly to the chest and can optionally act on the chest by programming the amount of power to be transmitted to the transducer 14 in a personalized form. The present invention can remove capsular contractures corresponding to degree IV at the Baker scale.

Description

EQUIPMENT FOR THE TREATMENT OF CAPSULAR CONTRACTURES IN MAMMAL IMPLANTS}

The present invention, according to the name, relates to a device for treating capsular contractures of mammalian implants and a method of applying the same. It brings remarkable safety and efficiency in its function.

The main consequence of rejection after surgical intervention with the aim of inserting a prosthesis into a woman's chest is the different degree of dish-like joint hardening around the inserted prosthesis. ) Is formed, which in some cases leads to new surgical interventions when so-called "capsulation" or encapsulation occurs.

The rejection response occurs one week or about one year after the invention, and until now there has been no explanation for this spread in the manifestation of rejection symptoms and the reason for this is currently unknown. Although the development of intubation designs and the selection of suitable materials for prosthetics have contributed to the reduction of encapsulation cases, the percentage is still important and health authorities in many countries have recommended preventive measures to address this rejection problem.

Currently, when encapsulation problems are clinically detectable, it is common to conduct standard treatments with varying degrees of intensity massage to the chest.

Several studies conducted by Dr. Baker, the basis of clinical treatment, known under the name Baker, have demonstrated that the massage treatment can lead to a temporary solution in some cases, but does not prevent the recurrence of the disorder.

The present invention describes the problem of formation and rejection of the aforementioned coatings that avoid the surgical intervention required in some cases as well as current hand treatment. The present invention provides for the treatment by ultrasound, which has been found to be highly effective in completely external to the body and against the biological mechanisms underlying the formation of the coating, which is carried out with other embodiments, parameters, and devices. It has already produced meaningful results in problems such as cellulitis, keloid scars and other similar disorders.

Another object of the present invention is a method for applying the device for the purpose of overcoming different degrees of film construction by a corresponding procedure.

Two years ago the inventors started a test to apply external therapy by ultrasound with the device which is the subject of the invention and the test resulted as summarized below. The present invention has been found to be effective in the most severe cases of encapsulation on the cannula and to prevent recurrence.

Testing with the device, which is the subject of the present invention, has a total of 34 insertion canals in the chest (unilateral chest 14 and bilateral chest 10), classified as varying degrees of "construction" according to the Baker scale shown in Table I. The study was conducted with a panel of 24 patients consisting of between 24 and 52 years of age.

Eighteen of the patients had a subglandular intubation, three others had a retropectoral intubation, and two patients had post-mastectomy reconstructions. In one case, the patient had an unknown type of artificial organ.

Of the thirty-four artificial organs inserted into the patient, 23 were silica gel implants, 4 were soybean oil implants, and 7 were unknown sources. Capsulations occurred within a period comprised between 22 weeks and 4 years, with an average of about 6 months after surgical intervention for insertion of the prosthesis.

The chest with contractions all experienced a first film formation following the technical crimping method proposed by Baker in 1976. Hand therapy was unsatisfactory in three of the cases that had a construction corresponding to category IV. However, after the mild session of the ultrasonic waves generated by the device of the present invention, it was effective to stop the construction.

The ultrasonic generator was connected to eight transducers to emit ultrasonic waves having a variable output power adjustable between 1 and 15 watts, generating a maximum power having an operating frequency of 0.15 to 7 MHz and a density of 3 watts / cm 2.

Four transducers were applied to each chest, placed towards the skin and attached to a special leash. See FIG. 2.

The ultrasonic generator of the present invention has two modes of operation: continuous mode and pulsating mode. In any case, the device determines the value of power dissipated for each outlet and then automatically determines the duration of the distribution and the period required by the converter. If an adjustable pulsating system is used for treatment in the subglandular or pectoral posterior position, the release cycle is five times longer to minimize the effect of ultrasound energy on biological tissue. Pulsating systems were initially used to supply the same amount of energy. The system was then favored for future investigations because of the better clinical results obtained in mitigating the coating and preventing any adverse effects that may occur in patients with excessive heating.

One of the preferred solutions used in the ultrasonic generator according to the invention is to use a power outlet of 15 watts per cycle with a power density of 600 mW / cm 2 for any of the transducers. The number of cycles for ultrasound application was adjusted to take into account the clinical response and the importance of construction and the number of treatment periods by ultrasound. Ultrasound therapy was programmed twice a week and extended until stable and satisfactory results were obtained. The required treatment session for an average of 5.27 was determined with 15 to 36 cycles of ultrasound application per period.

The results obtained by the application of the present invention with repeated application of ultrasound energy and the results of follow-up monitoring for 12 months of treatment are shown in Tables II and III. No complications were seen during the test. After the ultrasound treatment, the patient felt tenderness in the chest without any uncomfortable feeling due to excessive heating. In three cases corresponding to class IV in the Baker scale, the compression of the encapsulation was removed after only one (ultrasonic) treatment session. Finally, the most extensive long-term report on the results of capsulotomy by closed compression was published by Little and Baker in 1980. These investigators produced a report on a wide range of sample patients whose highest recurrence rate after encapsulation treatment was found about 6 months after treatment and the total relapse rate after 12 months was set at a percentage of at least 33%. Regardless of the severity of the pre-treatment membrane, only 67% of the treated patients had satisfactory and long lasting results.

In the tests conducted by the inventors, although the number of patients was small, 82.27% of the patients showed no clinical signs of encapsulation after 12 months of follow-up monitoring (see Table III). This data should be considered taking into account the severity of construction during treatment. According to the Baker report, the rate of serious cases was estimated to be about 62% (degrees III and IV), which percentage is really low compared to the series of tests conducted by the inventors (97%, see Table I).

Other details and features of the present invention will be demonstrated by the following detailed description, which refers to the accompanying drawings in which relevant details are shown schematically. These details are examples illustrating possible embodiments of the present invention, not limited to this detailed description. Therefore, this detailed description should be considered as an example of description without any excessive limitation.

The following reference numbers correspond to the detailed description and the accompanying drawings: (10) device components, (11) displays, (12) control systems, (13) power supplies, (14) converters, (15) keyboards, (16) attachments Attachment harness (16).

According to one of the preferred embodiments shown in the block diagram of FIG. 1, reference numeral 11 denotes a display for operating parameters for the device. The device is connected to a control system 12 for the power source 13 and the multiple ultrasound transducers 14. Both data entry and control systems are managed by the keyboard 15.

The control system 12 utilizes a microprocessor that performs all the monitoring and control tasks of the system. The input of parameters and data is carried out by the keyboard 15 and the monitoring is carried out in a viewer 11 which usually consists of a liquid crystal display. The multiple ultrasound transducers 14 are attached directly to the body part to be treated and are connected to a power source 13 which is adjustable by the control system 12.

As shown in FIG. 2, the transducer 14 is positioned by a leash 16 to attach to the chest of the patient. The embodiment shown in FIG. 2 is not unique but is only one of the possible embodiments of the present invention as the treatment may be made selectively for:

-Both chests at once

-Right chest

-Left chest

Also depending on the type of intubation, the transducer 14 may be placed above or below the holding means enabling treatment of the intubation in a linear or pectoral posterior position.

Energy transfer to the converter 14 may optionally be carried out as follows:

-Same power input for all transducers

-With the same power input for the transducer corresponding to one of the sides (right chest or left chest)

-With different power for each side

The converter located at the top has a different power than the converter located at the bottom.

Taking into account the degree of construction according to the Baker scale and the type of insertion tube, the process for applying the device consists of at least the following steps:

-Choose between two modes of operation: continuous mode or pulsating mode.

-Select the power supply for the transducer (14).

Power the converter (14).

-Select the operating frequency.

The duration and frequency of the ultrasonic application depends on the degree of construction and in all cases relates to the values expressed in the tests and tables described herein.

While the invention has been described fully in accordance with the foregoing description and the accompanying drawings, it will be appreciated that any modifications may be made without departing from the scope of the invention as outlined in the following claims.

By means of the device according to the invention it is possible to overcome different levels of film construction.

1 is a block diagram with the main elements of the device 10.

2 is a view of each of the attachment means for the transducer 14.

Claims (7)

The device 10 has support means for supporting a transducer 14, such as a leash 16, emits energy in the form of ultrasonic waves to the transducer within a power range of 1 to 15 watts, Also generates a power density of 3 watts / cm ² , in which the device 10 has a viewer 11 for operating parameters which control for controlling the power source 13 and the multiple ultrasonic transducers 14. Apparatus for the construction of a mammalian cannula for surgical application of female breast prostheses of a type comprising silica gel, soybean oil, characterized in that it is connected to the system and controlled by a keyboard 15. 2. The apparatus of claim 1, wherein the energy in the form of ultrasound can be released in continuous or pulsating mode. 2. The control system of claim 1, wherein the control system 12 uses a unique processor to perform all monitoring and control tasks of the system, the input of parameters and data by the keyboard 15 and the monitoring is generally of a liquid crystal display type. Ultrasonic transducer 14 carried by the viewer 11 and to be attached directly onto the body surface to be treated is connected to a power source 13 controlled by the control system 12. . 4. A power control means consisting of a combination of the power source 13 and its control system 12 is capable of supplying the same power to all the transducers 14 placed on both chests. Apparatus for treatment of encapsulation of a mammalian cannula. 4. The power regulating means of claim 1 or 3, wherein the power regulating means for coupling the power source 13 and its control system 12 can supply the same or different amounts of power to the converter 14 located above or below the supporting means. Capsular contracture treatment device for mammalian insertion tube, characterized in that the The device of claim 1, wherein the method for attaching the device comprises at least the following steps: -Select one of two modes of operation depending on continuous mode or pulsation mode. Select the power to be supplied to the converter 14. Power the converter (14). -Select the operating frequency. The device of claim 1, wherein the operating frequency of the device is comprised between 0.5 MHz and 7 MHz.